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Hepatitis C, Chronic clinical trials

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NCT ID: NCT00352235 Completed - Chronic Hepatitis C Clinical Trials

Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection

Start date: August 2003
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I/II trial of KRN7000 in patients with chronic hepatitis C. Study objectives: To evaluate and compare the safety and tolerability of 3 ascending doses of a-GalCer. The primary efficacy parameter: HCV-RNA response at the end of treatment. Secondary efficacy parameter: Serum ALT response. Further objectives of the study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells. Number of dose levels: 3 Investigational product: KRN7000 Route of administration: intravenous Dosages and frequency: 0.1, 1, 10 mcg/kg, monthly injection, 3 times (day 0, day 28 and day 56)

NCT ID: NCT00351871 Completed - Chronic Hepatitis C Clinical Trials

Influence of Marker of Insulin Resistance Upon Hepatitis C Virus (HCV) Treatment Responses to PEG Intron and Rebetol Therapy

Start date: April 2002
Phase: Phase 4
Study type: Interventional

The objective of this study is to better understand the influence of insulin resistance upon treatment response in hepatitis C virus treated with PEG Intron and Rebetol.

NCT ID: NCT00351403 Completed - Clinical trials for Hepatitis C, Chronic

Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection

Start date: July 2006
Phase: Phase 4
Study type: Interventional

Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for others too short. An individually adapted therapy length from 24 to 72 weeks will be determined in dependence of the initial virus load and the time to HCV RNA negativity. The primary objective is to compare the cumulative rate of the sustained viral response (SVR) of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy.

NCT ID: NCT00343525 Completed - Hepatitis C Clinical Trials

Repeat-Dose Study of Bavituximab in Patients With Chronic Hepatitis C

Start date: May 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of bavituximab when administered via an arm vein as multiple infusions and to examine how bavituximab behaves in the body and how it effects the amount of hepatitis C virus and immune modulators in individuals with chronic infection.

NCT ID: NCT00336479 Completed - Chronic Hepatitis C Clinical Trials

Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

Start date: June 2006
Phase: Phase 2
Study type: Interventional

Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

NCT ID: NCT00323804 Completed - Clinical trials for Hepatitis C, Chronic

Interest of Ribavirin in the Maintenance Treatment of Liver Fibrosis Using Low Dose Pegylated Interferon alpha2b in Patients With Chronic Hepatitis C Non Responders to Previous Antiviral Therapy.

Start date: May 2006
Phase: Phase 2/Phase 3
Study type: Interventional

Patients with chronic hepatitis C who did not respond to previous antiviral treatment develop liver fibrosis leading to cirrhosis. Maintenance low dose pegylated interferon therapy of fibrosis is currently under investigation in large multicenter trials. The aim of our study is to assess if peginterferon alpha2b plus ribavirin is more efficient than peginterferon alpha2b alone. 454 patients will be randomized between the 2 arms and the efficacy will be assessed, after 3 years of treatment, on Metavir liver fibrosis score improvement.

NCT ID: NCT00322179 Completed - Obesity Clinical Trials

Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C

Start date: November 2005
Phase:
Study type: Observational

The response rate to interferon-based anti-viral therapy for chronic hepatitis C is lower in patients who are obese. However, it is not clear whether this is related to suboptimal dosing of the medication or alterated response in obese patients. Alterated immune response had been reported in obese patients. The goal of current study is to determine the immune response to interferon in obese compared to non-obese chronic hepatitis C in an tissue culture system.

NCT ID: NCT00310336 Completed - Hepatitis C Clinical Trials

Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine

Start date: August 2006
Phase: Phase 2/Phase 3
Study type: Interventional

50-60% of patients with chronic hepatitis C are not cured by treatment with pegylated IFNα plus ribavirin. Retreatment of non-responders of previous (pegylated) IFNα plus ribavirin therapies with pegylated IFNα plus ribavirin results in a sustained response in less than 10% of the patients. Extensive analysis of IFNα signaling in cells expressing HCV proteins, in transgenic mice expressing HCV proteins, and in liver biopsies from patients with chronic hepatitis C point to STAT1 methylation as an important posttranslational modification targeted by HCV to inhibit IFNα signaling. STAT1 methylation can be increased and IFNα can be improved by adding AdoMet and betaine. The study is designed to test the hypothesis that a combination treatment with pegylated IFNα2b, ribavirin, AdoMet and betaine is superior to the current standard combination therapy with pegylated IFNα plus ribavirin.

NCT ID: NCT00304551 Completed - Liver Cirrhosis Clinical Trials

A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)

Start date: June 2006
Phase: Phase 3
Study type: Interventional

This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC. Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.

NCT ID: NCT00302081 Completed - Clinical trials for Hepatitis C, Chronic

Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548)

Start date: August 2003
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.5/R (24 weeks)], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily [Arm PEG2b 1.0/R (24 weeks)], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks [Arm PEG2b 1.5/R (16 weeks)] .